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PV Express II for Licensed Establishments – Guidance Document 

Instructional Guidance for PV Express II for Licensed Establishments

The PV Express II web-based form is one of two approved methods licensed establishments may use to submit individual 

adverse event reports (AER) to the Center for Veterinary Biologics (CVB). The PV Express II web-based form can be 

accessed here. The other approved method licensed establishments may use to submit adverse event reports to the 

CVB is through the electronic Gateway, which is only for transmissions of AERs created in XML format. For further 

information on the Gateway, contact the CVB.

The step-by-step instructions provided in this guidance document are to aid your establishment in completing the PV 

Express II web-based form.

VeDDRA Coding of Clinical Symptoms Reported in an Adverse Event Report

For each of the clinical symptoms described in an individual adverse event report (AER) the licensed establishment

submitting the report must assign an acceptable term to each symptom in accordance with the Veterinary Dictionary for 

Drug Related Affairs (VeDDRA) vocabulary listing. The VeDDRA vocabulary listing is an internationally harmonized list of 

medical terms used to describe the adverse clinical manifestations identified in an AER and is accepted by the

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal 

Products (VICH). The most current VeDDRA list can be accessed here: VeDDRA complete list. Guidance Notes for the 

Use of VeDDRA Terminology for Reporting Adverse Events in Animals’ can be accessed here: Guidance notes on the use 

of VeDDRA terminology. Diagnostic test kit manufacturers reporting an adverse event will only code the VeDDRA term 

“unclassifiable adverse event” and only code one term per event. Use the event narrative to provide complete details.

Causality Assessment by the Market Authorization Holder (MAH) for an AER Submitted to CVB

In addition to VeDDRA coding, licensed establishments must also assign a ‘causality’ for each of their products 

associated with the AER. Each establishment will make a determination as to whether the adverse reaction noted in an 

individual AER is related to their biological product. For the purposes of reporting adverse events to the CVB under Title

9 Code of Federal Regulations (CFR), the ‘ABON system’ for assessing causality is the acceptable method to be used.

• Category A: Probable - All of the following minimum criteria should be present:

o There should be a reasonable association in time between the administration of the biological product 

and onset and duration of the reported adverse reaction.

o The description of the clinical event should be consistent with, or at least plausible, given the known 

ingredients of the biological product described in the adverse event.

o There should be no other equally plausible explanation(s) of the case reported. 

• Category B: Possible -The administration and/or use of the biological product is another possible and plausible 

cause for the reported adverse event where the available data do not meet the criteria for inclusion in Category A. 

• Category O: Unclassifiable/Unassessable - Applied to cases where reliable data is unavailable or insufficient to 

make an assessment of causality.

• Category O1: Inconclusive – Applied to cases where other associated factors prevented the assessor from drawing 

a definitive conclusion regarding causality (A or B), but in which association cannot be discounted.

• Category N: Unlikely - Sufficient information exists to establish beyond a reasonable doubt that the adverse 

reaction described in the adverse event report was not likely due to the use of the veterinary biological product.

NOTE: ALL FIELDS on the PV Express II web-based form should be completed if known by your firm. All date fields 

appear on the form as European dates (DD-MM-YYYY). To delete a case already submitted, contact CVB.

Should you have any questions, need assistance or need to report system problems, please contact Dr. Bill Huls or Dr. 

John Schiltz at CVB.Pharma@usda.gov or at (515) 337-6100.
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PV Express II for Licensed Establishments – Guidance Document 

https://cvbpv.aphis.usda.gov/PVXClient/index.html

Start the AER by clicking here.

Then, clicking here.

Click on the Reporting for 

Manufacturers Report.

URL to initiate an adverse event 

report.
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PV Express II for Licensed Establishments – Guidance Document 

These 5 sections

contain mandatory

and optional 

requirements. Once 

the mandatory items 

are completed, the 

icon preceding the 

section name will 

change (eg. or ). 

Instructions for 

completing each 

section will be covered 

in this document.

These 4 sections allow 

for the reporting of 

additional products, 

VeDDRA signs, and 

reporters.

This final grouping 

allows you to check 

the report for errors, 

rename the report, or

delete the report.
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PV Express II for Licensed Establishments – Guidance Document 

Establishment Case Overview 1: This is the screen as it initially appears. Mandatory fields are denoted with red 

asterisks (*). Remember, fill in ALL fields if they are known to you. Some fields have default values, which can be 

changed by selecting the down arrow at the right of the field. The down arrows at the right end of each field reveals a 

drop-down list to choose from.

The next picture shows the fields completed:
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PV Express II for Licensed Establishments – Guidance Document 

NOTE the date field is in European format

(DD-MM-YYYY). Click the calendar icon on 

the right of the field to select the date the 

adverse event was reported to your firm.

This section should 

contain information 

about the reporter, in 

this case the Vet Clinic. 

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left

corner of the screen.

Is this a serious adverse event? A serious 

adverse event is any adverse event which results 

in death, is life-threatening, results in persistent 

or significant disability/incapacity, or a congenital 

anomaly or birth defect. 

Select the appropriate reportability: 3-day 

alert for immediate (serious, unexpected and 

product related), periodic for all other initial 

reports. If a follow-up report, you must use 

the same Establishment Case # as the previous 

report.

Enter your establishment-assigned AER case 

number.

Two options: Animal Complaint (adverse event

in animal(s)) or symptomatic human case. 

Choose from the drop-down list an 

appropriate reporter role, and, if known, 

provide the clinic name

If the reporter requests anonymity, put 

“Anonymous” in the ‘Last name’ field.
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PV Express II for Licensed Establishments – Guidance Document 

Licensed Biological Product 1: This screen is as it initially appears. Enter information on this screen for your 

Establishment’s licensed product involved in this adverse event report. The down arrows at the right end of each field 

reveals a drop-down list to choose from.
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PV Express II for Licensed Establishments – Guidance Document 

Product role will always be “Suspect 

product” for products prepared by

your firm.

Establishment and Product Code 

for the product involved with this 

adverse event report. Combination 

package products licensed by APHIS 

do not receive APHIS release, 

however AERs involving combination 

package products are required to be 

submitted to CVB.

True name, Trade name, Serial number (if 

known) and expiration date of the product. 

NOTE – serial number is alphanumeric, do 

not use special characters (-,/, etc.) NOTE

expiration date is in European format.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left

corner of the screen.

Start date = date of administration. End date 

is used when vaccination extends over a 

period of time (vaccinating 500 calves over 

two days, for example). If part of a series of 

immunizations for an individual animal, 

please explain in the case narrative.

3 choices for this particular product: Adverse 

reaction, Human exposure – symptomatic, or 

Lack of efficacy.

If the product was NOT used per label 

instructions, pick the most appropriate 

category.

If this value is less than 1 (<1), you 

must enter a zero followed by the 

decimal, for example 0.5.

Enter your company assessment of 

causality.

Enter the attending veterinarian’s 

assessment of causality, if known.
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PV Express II for Licensed Establishments – Guidance Document 

Event 1: This screen is as it initially appears. Enter information on this screen to describe the actual adverse event. 

Provide a complete, detailed narrative. The down arrows at the right end of a field reveals a drop-down list to choose 

from.

Click the drop-down arrow and

select an outcome from the dropdown list.

If there is uncertainty about the 

date that the adverse event 

started, check this box.

How long did the adverse event last?

Provide a complete, detailed 

narrative of the adverse event.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.
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PV Express II for Licensed Establishments – Guidance Document 

VeDDRA Sign 1: This screen is as it initially appears. Enter a VeDDRA term for one of the clinical signs / symptoms for 

the actual adverse event. Additional signs will be added at a later screen. The down arrows at the right end of a field 

reveals a drop-down list to choose from.
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PV Express II for Licensed Establishments – Guidance Document 

Start by entering a sign / symptom

from the event narrative field in 

the “Low Level Term” field. As you 

type, possible terms appear in a 

scrollable box. Select the most 

appropriate term from the 

suggested terms (in this example, 

‘swelling’ was noted at the 

injection site, so select “Injection

site swelling”).

Once a term is selected, the 

remaining fields in the blue box are 

auto-populated.

These fields are auto-populated.

NOTE: Diagnostic test kit manufacturers 

reporting an adverse event will only code 

the VeDDRA term “unclassifiable adverse 

event” and only code one term per event. 

Use the event narrative to provide 

complete details.
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PV Express II for Licensed Establishments – Guidance Document 

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

Fill in the remaining fields, based 

on the narrative. Start date

(when symptoms appeared), End 

date (when symptoms went 

away), and Duration refer to the 

particular sign (VeDDRA term). 

In the example, injection site 

swelling was noted 4 hours after 

product administration and 

lasted 4 days.
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PV Express II for Licensed Establishments – Guidance Document 

Patient 1: This screen is as it initially appears. Enter patient information. The down arrows at the right end of a field

reveals a drop-down list to choose from.
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PV Express II for Licensed Establishments – Guidance Document 

No. of animals exposed = number 

of animals vaccinated

If numbers are approximations, 

check this box.

If a mixed breed, check the box 

and enter the other breed.

Allows for multiple ages for a group 

of animals or to provide an 

approximation of age (eg. 6-8 month 

old calves). If age is known, only 

need to enter the “Age from” field 

and select units.

Allows for weight range for a group 

of animals or to provide an 

approximation of weight (eg. 600-

800 pound calves). If weight is 

known, only need to enter the 

“Weight from” field and select units.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.
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PV Express II for Licensed Establishments – Guidance Document 

This completes the mandatory sections. However, in this example, there are more VeDDRA terms to be added to the 

case, and an additional product and reporter needs to be included.

To add additional VeDDRA terms, click on the “Add VeDDRA Sign” 

Follow the instructions provided previously for the VeDDRA Sign entry to complete the screens for additional VeDDRA 

signs. Account for ALL clinical signs/symptoms. In this example, we need to include limping:

Start by entering a sign / symptom 

in the “Low Level Term” field. As 

you type, possible terms appear in 

a scrollable box. Select the most 

appropriate term from the 

suggested terms (in this example, 

select “Limping”).
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PV Express II for Licensed Establishments – Guidance Document 

For the additional biological products that were administered:

• If the product(s) are produced or distributed by the firm filing this report, select “Add Licensed Biological 

Product” and follow the instructions for Licensed Biological Product. Remember to select “Suspect product” 

for the Product role field. All products produced or distributed by the firm filing the report are considered 

suspect products.

These fields are auto-populated.

Once a term is selected, the 

remaining fields in this picture are 

auto-populated.

Fill in the remaining fields, based on 

the narrative. Start date (when 

symptoms appeared), End date 

(when symptoms went away), and 

Duration refer to the particular sign 

(VeDDRA term). In the example, 

limping was noted 4 hours after 

product administration and lasted 

two days.
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PV Express II for Licensed Establishments – Guidance Document 

• If the product(s) were produced by a different firm, select “Add Other Product.” See example below.

For products produced by a 

different firm, always select 

“Concomitant”.

Fill out all the fields as 

completely and accurately as 

possible.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

In this example, the attending vet felt 

that this product was “unlikely” to have 

contributed to the adverse event.
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PV Express II for Licensed Establishments – Guidance Document 

To add additional reporters (owner, vet clinic), select “Add Reporter.” See example below.

Fill out all the fields as 

completely and accurately as 

possible.

Once all information is entered, 

click “Save and close.” Note you 

can click here or on the top left 

corner of the screen.

Select additional reporters from 

the drop-down list.
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PV Express II for Licensed Establishments – Guidance Document 

The final step involves checking the report for errors. If an error is found, you will be directed to correct the error and 

then allowed to submit the report.

If there are no errors, select continue:

You can rename the report.

Enter a new name and then select 

“Rename.”
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PV Express II for Licensed Establishments – Guidance Document 

Select “Submit report.”

You will get a “confirmation” screen:

Note the Report name (you 

renamed it; default name is 

“Establishment report.”) and the 

Report ID. The Report ID is a 

useful field for CVB to find your 

report.

Select View summary. 

This will allow you to 

see, save, and print 

the report. This 

provides 

documentation of the 

report.
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PV Express II for Licensed Establishments – Guidance Document 

Enlarged view of beginning of report.

 Enlarged view of bottom of report.

While too small to read in this 

picture, the summary contains all 

of the data you entered into the 

report.

TO SAVE A COPY OF THE REPORT, 

select Print Summary Report.
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PV Express II for Licensed Establishments – Guidance Document 

Finally, select “Home” to start a new report or exit the AER web-based reporting application.

From the print screen, select 

“Adobe PDF” as the printer, and 

then select Print. You will be 

asked where to store the PDF 

file that is generated on your 

computer / network. Consider

naming the file in a manner that 

facilitates organizing and 

retrieval of the adverse events 

you are reporting. Firms are 

required to maintain Adverse 

Event Report records for 3 

years.